Syringes with Luer Lock Recalled for Blood Backfill and Foreign Material Risk
Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I classifications carry a minimum severity of Severe (4), as they can cause serious adverse health consequences. No deaths or serious injuries have been reported for this product; the hazard is potential rather than realized.
Plain-English summary
Fresenius Medical Care Holdings, Inc. has initiated a recall of 3ML Syringes with Luer Lock needles, 20 gauge x 1 inch (Part Number 15-03ML-0, UDI-DI: 16945060500101). All lots of this product are included in the recall, affecting 124,773 boxes distributed throughout the United States.
The syringes present a potential risk of blood backfill leakage and foreign material contamination. Blood backfill occurs when blood flows backward into the syringe during use, potentially introducing foreign material or causing exposure to blood. This is a Class I recall by the FDA, indicating a serious potential health risk.
The recalled product
- Product
- 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Syringes
- Affected units
- 124,773
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 16945060500101
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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